MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 23AGFN-756

Device Problems Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem Aortic Regurgitation (1716)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation indicated the 23 mm regent valve met abbott functional specifications.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.Leaflet mobility testing at the time of manufacturing and hydrodynamic testing upon return to abbott indicated the valve functioned normally.The cause of the reported event remains unknown.

Event Description

On (b)(6) 2017, this 23 mm regent valve was implanted.At the time of discharge, an echocardiogram showed regurgitation with one leaflet lagging in movement.On (b)(6) 2017, the valve was explanted and another 23 mm regent valve was implanted.The patient was reported to be in stable condition.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6798038
• MDR Text Key: 82813739
• Report Number: 2648612-2017-00070
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: 23AGFN-756
• Device Catalogue Number: 23AGFN-756
• Device Lot Number: 5501311
• Other Device ID Number: 05414734006095
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 65